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J18161-ADaptiVe Biomarker Trial that InformS Evolution of Therapy (ADVISE)
Protocol Number:
Phase I
Katherine Bever
Johns Hopkins Kimmel Cancer Center in Baltimore
Multicenter, Phase 1 Open-Label study. The goal of the study is to focus on understanding the ability to collect and analyze tumor biopsies of adequate quality that can be quickly analyzed for specific immunologic markers in time to aid in choosing appropriate combination immunotherapy/stereotactic body radiation therapy (SBRT). (The specific immunologic biomarkers for this study are: natural killer p46 (NKp46), lymphocyte activation gene 3 (LAG-3), colony-stimulating factor 1 receptor – CSF1R, forkhead box P3 – FoxP3, indoleamine2, 3-dioxygenase – IDO, anti-glucocorticoid-induced tumor necrosis factor receptor TNFR, cluster of differentiation 8 – CD8, and programmed death ligand – PD-L1). Biomarker analyses prior to treatment could help direct subsequent treatment in a clinically meaningful way; however, the feasibility of the use of biomarker data in specific study populations, in conjunction with exploratory efficacy of combination IO drugs, has not been assessed. Biomarker analyses prior to treatment could help direct subsequent treatment in a clinically meaningful way.
Men or women, greater than / equal to 18 years of age, with selected solid tumors and an Eastern Cooperative Oncology Group (ECOG) performance status of greater than / equal to 1, and have at least 2 lesions with measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST). Patients must have had prior therapy (may have had IO therapy - at least 10 participants must be IO-naïve). Patients must not have received the investigational combinations. Patients must provide a pre-treatment biopsy and have histologic confirmation of melanoma, non-small cell lung cancer, renal cell carcinoma, urothelial bladder cancer, squamous cell cancer of the head and neck (SCCHN), or gastric or gastroesophageal junction cancer (GEC).
Eligible patients will receive treatment with Nivolumab in combination with immunotherapy agents that have a complimentary mechanism of action. Each of the immunotherapy agents will have already been testing in independent studies to determine a tolerable and pharmacologically active dose and dosing regimen. The agents selected for combination with nivolumab will each target immunologic markers, which are likely relevant in regulating anti-tumor immunity and which may be co-opted by the tumor to evade immune detection. Patients with either MEL, NSCLC, RCC, UCC, SCCHN, or GEC may be enrolled.
Last Update
08/08/2020 05:02 AM